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Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm

We compared overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2)–amplified, treatment-refractory metastatic colorectal cancer (mCRC) receiving pertuzumab plus trastuzumab (PER-HER) in the phase IIa MyPathway multibasket study (ClinicalTrials.gov identifier: NCT02091...

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Autores principales: Narita, Yusuke, Yoshimoto, Takuya, Namai, Tomoyuki, Asakawa, Takashi, Kawakami, Satoe, Gower-Page, Craig, Reyes-Rivera, Irmarie, Patel, Arisha, Nakamura, Yoshiaki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9225680/
https://www.ncbi.nlm.nih.gov/pubmed/35649212
http://dx.doi.org/10.1200/CCI.22.00022
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author Narita, Yusuke
Yoshimoto, Takuya
Namai, Tomoyuki
Asakawa, Takashi
Kawakami, Satoe
Gower-Page, Craig
Reyes-Rivera, Irmarie
Patel, Arisha
Nakamura, Yoshiaki
author_facet Narita, Yusuke
Yoshimoto, Takuya
Namai, Tomoyuki
Asakawa, Takashi
Kawakami, Satoe
Gower-Page, Craig
Reyes-Rivera, Irmarie
Patel, Arisha
Nakamura, Yoshiaki
author_sort Narita, Yusuke
collection PubMed
description We compared overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2)–amplified, treatment-refractory metastatic colorectal cancer (mCRC) receiving pertuzumab plus trastuzumab (PER-HER) in the phase IIa MyPathway multibasket study (ClinicalTrials.gov identifier: NCT02091141) with OS in those receiving routine clinical care in an electronic health record–derived external control arm. METHODS: A noninterventional study was conducted using patient-level data from MyPathway participants receiving PER-HER and real-world patients with HER2-amplified treatment-refractory mCRC receiving routine clinical care. This study used a deidentified US-based clinico-genomic database (CGDB). For patients in the CGDB who met study eligibility criteria at multiple index dates (treatment initiation dates in the treatment-refractory setting), all eligible index dates were used for the analysis. Standardized mortality ratio weighting on the basis of propensity score derived a pseudopopulation (postweighting population) balancing key prognostic variables between arms. Multivariate Cox proportional hazards models were used for estimation of the hazard ratio (HR) in the primary OS analysis. A series of sensitivity analyses were conducted to investigate the robustness and consistency of the primary analysis. RESULTS: The PER-HER arm comprised 57 patients enrolled in the MyPathway study by August 1, 2017 (data cutoff); the external control arm comprised 18 patients (27 index dates) with HER2-amplified mCRC who met the major MyPathway eligibility criteria in CGDB collected between 2011 and 2019. The estimated HR for OS from the multivariate Cox proportional hazards model in the postweighting population was 0.729 (95% CI, 0.184 to 3.900). The results of sensitivity analyses were consistent with the primary analysis in terms of the point estimate of HR. CONCLUSION: Despite a small sample size, these findings suggest that PER-HER could have a potential OS benefit for this population.
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spelling pubmed-92256802022-06-24 Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm Narita, Yusuke Yoshimoto, Takuya Namai, Tomoyuki Asakawa, Takashi Kawakami, Satoe Gower-Page, Craig Reyes-Rivera, Irmarie Patel, Arisha Nakamura, Yoshiaki JCO Clin Cancer Inform ORIGINAL REPORTS We compared overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2)–amplified, treatment-refractory metastatic colorectal cancer (mCRC) receiving pertuzumab plus trastuzumab (PER-HER) in the phase IIa MyPathway multibasket study (ClinicalTrials.gov identifier: NCT02091141) with OS in those receiving routine clinical care in an electronic health record–derived external control arm. METHODS: A noninterventional study was conducted using patient-level data from MyPathway participants receiving PER-HER and real-world patients with HER2-amplified treatment-refractory mCRC receiving routine clinical care. This study used a deidentified US-based clinico-genomic database (CGDB). For patients in the CGDB who met study eligibility criteria at multiple index dates (treatment initiation dates in the treatment-refractory setting), all eligible index dates were used for the analysis. Standardized mortality ratio weighting on the basis of propensity score derived a pseudopopulation (postweighting population) balancing key prognostic variables between arms. Multivariate Cox proportional hazards models were used for estimation of the hazard ratio (HR) in the primary OS analysis. A series of sensitivity analyses were conducted to investigate the robustness and consistency of the primary analysis. RESULTS: The PER-HER arm comprised 57 patients enrolled in the MyPathway study by August 1, 2017 (data cutoff); the external control arm comprised 18 patients (27 index dates) with HER2-amplified mCRC who met the major MyPathway eligibility criteria in CGDB collected between 2011 and 2019. The estimated HR for OS from the multivariate Cox proportional hazards model in the postweighting population was 0.729 (95% CI, 0.184 to 3.900). The results of sensitivity analyses were consistent with the primary analysis in terms of the point estimate of HR. CONCLUSION: Despite a small sample size, these findings suggest that PER-HER could have a potential OS benefit for this population. Wolters Kluwer Health 2022-06-01 /pmc/articles/PMC9225680/ /pubmed/35649212 http://dx.doi.org/10.1200/CCI.22.00022 Text en © 2022 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle ORIGINAL REPORTS
Narita, Yusuke
Yoshimoto, Takuya
Namai, Tomoyuki
Asakawa, Takashi
Kawakami, Satoe
Gower-Page, Craig
Reyes-Rivera, Irmarie
Patel, Arisha
Nakamura, Yoshiaki
Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title_full Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title_fullStr Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title_full_unstemmed Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title_short Pertuzumab Plus Trastuzumab for Treatment-Refractory HER2-Amplified Metastatic Colorectal Cancer: Comparison of the MyPathway Trial With a Real-World External Control Arm
title_sort pertuzumab plus trastuzumab for treatment-refractory her2-amplified metastatic colorectal cancer: comparison of the mypathway trial with a real-world external control arm
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9225680/
https://www.ncbi.nlm.nih.gov/pubmed/35649212
http://dx.doi.org/10.1200/CCI.22.00022
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